CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69,274 enrolled
Drug / intervention
Rotateq™ +1 morebiological
Likely dose
RotaTeq 2.0 mL orally, 3 doses given at study entry and 4-10 weeks apartAI-extracted
Key inclusion· 1
  • ✓Healthy infants
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090233
NCT00090233Phase 3Completed
CompareCT.gov

Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

Merck Sharp & Dohme LLC·interventional·Posted Aug 27, 2004·Updated Oct 5, 2015

In Brief

A Phase 3 clinical trial evaluating Rotateq™ and Comparator: Placebo for Rotavirus Infections. Completed, enrolled 69,274 participants.

Detailed Summary

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Infections
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2004
Enrollment StartJan 1, 2001
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.8 years ago

Interventions

Rotateq™biological

3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.

Comparator: Placebobiological

3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.